Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT01004991
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    375 mg/m2 on Day 8 of each of 6 cycles
  • cyclophosphamide — DRUG
    750 mg/m2 on Day 8 of each of 6 cycles
  • vincristine — DRUG
    1.4 mg/m2 on Day 8 of each of 6 cycles
  • doxorubicin — DRUG
    50 mg/m2 on Day 8 of each of 6 cycles
  • prednisone — DRUG
    100 mg PO days 8-12 of each of 6 cycles
  • azacytidine — DRUG
    Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5

Study Details

This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion will then evaluate efficacy of the combination at the established MTD.

Key Dates

Start date
Jan 31, 2010
Status verified
Feb 2017
Primary completion
Sep 30, 2013
Completion
Feb 29, 2016

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All patients
    subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP

Primary Outcome Measure

Complete Response [ Time Frame: 13 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical CollegeNew YorkNew York10065-

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By research site
Weill Cornell Medical College· New York, NY

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